Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia

NCT00506961 | Completed Phase 4

• 1 other identifier: AZ-RSV-RT-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is superior to simvastatin 40 mg in achieving the combined goal of LDL-C (\<100 mg/dL) and non-HDL-C (\<130 mg/dL).

Conditions

Diabetes Mellitus; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• The percentage of patients achieving the combined treatment goal of LDL-C < 100mg/dl and non-HDL-C < 130 mg/dl at week 12 with rosuvastatin treatment compared with simvastatin treatment

  12 weeks

Secondary Outcomes (3)

• Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4;

  4 weeks

• Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12;

  12 weeks

• Percentage of patients achieving the LDL-C goal of <70 mg/dL at Week;The mean percent change from baseline in lipid profile at week 4 and week 12;

  12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks

Drug: Rosuvastatin

2

ACTIVE COMPARATOR

20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks

Drug: Simvastatin

Interventions

Rosuvastatin DRUG

10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks

Also known as: crestor

1

Simvastatin DRUG

20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks

Also known as: zocor

2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female between the ages of 20-75 years.
• Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control.
• Diagnosed with type 2 diabetes mellitus.
• Fasting triglyceride ≧150 mg/dL ≦500 mg/dL or Non-HDL-C≧130,but≦200 mg/dL
• Patients receiving stable antidiabetic treatment for 8 weeks before randomization (no change in the category of anti-diabetic agents, but the dose is adjustable).
• All patients give written informed consent.

You may not qualify if:

• A history of hypersensitivity to statins.
• A history of rhabdomyolysis or hereditary muscle disorders.
• Insulin-treated patients.
• Patient with any conditions of acute or chronic pancreatitis.
• Creatine kinase ≧3-fold upper limit of normal (ULN).
• Patients with an estimated creatinine clearance (see note)≦30 ml/min or bilirubin ≧1.5-fold ULN, or chronic active hepatitis or liver function impairment (AST and ALT ≧3-fold ULN).
• Overt proteinuria (repeat spot urine protein \>300mg/dl by dipstick method).
• Patients are taking cyclosporine.
• A history of homozygous familial hypercholesterolemia or familial dysbetalipoproteinemia.
• Patients with alcohol and drug abuse in past 3 years.
• Serious or unstable medical or psychological conditions.
• Hypothyroidism (TSH \> 5 μIU/mL).
• In the investigator's opinion, continuation in the study would be detrimental to the patient's well-being or might confound the clinical trial.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (2)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Wu TH, Lee IT, Ho LT, Sheu WH, Hwu CM. Combined lipid goal attainment in patients with type 2 diabetes and dyslipidemia: A head-to-head comparative trial of statins. J Chin Med Assoc. 2022 Aug 1;85(8):831-838. doi: 10.1097/JCMA.0000000000000765. Epub 2022 Jun 20.

  PMID: 35727095 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Dyslipidemias

Interventions

Rosuvastatin Calcium; Simvastatin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds

Study Officials

• Chii-Min Hwu, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

• Wayne H Sheu, MD,phD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 25, 2007
• Study Start: June 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

TW (2)